Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas (RELIEF)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Empyema, Pleural; Pleural Infection

Treatments: Other: Saline Flush

Study type: Interventional

Funder types: Other

Identifiers

NCT06427538

231367

Details and patient eligibility

About

Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.

Full description

There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of <16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy
• Age > 18 years old.

Exclusion criteria

• Patients who have surgical tubes that can't accommodate a three-way stopcock.
• Study subject has any disease or condition that interferes with the safe completion of the study.
• Inability to provide informed consent.
• Inability to undergo a chest X-ray.
• If the managing clinician believes the chest tube will be placed for less than 24 hours.
• Patients with an indwelling pleural catheter (IPC)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Saline Intervention Arm

Experimental group

Description:

Patient will receive 20 mL sterile saline flushes into their catheter by study team members every 6 ± 2 hours. If patients are receiving intrapleural tissue plasminogen activator and deoxyribonuclease therapy, each treatment will be considered one flush.

Treatment:

Other: Saline Flush

No Intervention Arm

No Intervention group

Description:

Patient will receive a saline flush as needed, to restore patency of a chest tube considered blocked. No routine flushes will be administered.